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510(k) K870439

LOOK IRRIGATING CYSTOTOMES by Look, Inc. — Product Code HNY

K870439 is an FDA 510(k) premarket notification submitted by Look, Inc. for the device "LOOK IRRIGATING CYSTOTOMES". The FDA issued a decision of Substantially Equivalent on February 20, 1987. The device falls under product code HNY (Cystotome), a Class I device regulated under 21 CFR 886.4350. Look, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1987
Date Received
February 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystotome
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Look, Inc.

  • K943949 — POLYVIOLENE SURGICL SUTURE (November 10, 1994)
  • K933686 — LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE (December 23, 1993)
  • K926586 — REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES (December 22, 1993)
  • K926587 — REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) (December 17, 1993)
  • K926588 — REVISED LABELING FOR POLYPROPYLENE SUTURE (December 17, 1993)
  • K926168 — SILK SUTURES-REVISED LABELING (December 17, 1993)
  • K926167 — POLYVIOLENE SUTURE-REVISED LABELING (December 17, 1993)
  • K913530 — LOOK VISCODISSECTOR (October 21, 1991)
  • K903029 — STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE (October 25, 1990)
  • K903584 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (October 11, 1990)

Other clearances for product code HNY

  • K961524 — STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPU (May 16, 1996)
  • K880345 — CYSTOTOMES/KNIFES (May 3, 1988)
  • K875001 — PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME (April 13, 1988)
  • K874975 — PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME (April 13, 1988)
  • K874993 — PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K874983 — PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME (April 13, 1988)
  • K874997 — PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME (April 13, 1988)
  • K874976 — PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K873163 — VAN DELLEN IRRIGATING CYSTOTOME (September 4, 1987)
  • K871365 — CAPSULECTOMER CYSTOTOME (April 16, 1987)

FDA data resources